Journal of Clinical Psychiatry 2010;71(12):1680-1688. [doi: 10.4088/JCP.09m05089gry]
Theresa M. Winhusen, PhD (University of Cincinnati/CinARC, OV Node), Eugene C. Somoza, MD, PhD (University of Cincinnati/CinARC, OV Node), Gregory S. Brigham, PhD (Maryhaven, Inc., OV Node), David S. Liu, MD (Center for the Clinical Trials Network, NIDA), Carla A. Green, PhD, MPH (Kaiser Permanente Northwest, OR/HI Node), Lirio S. Covey, PhD (Columbia University Medical Center, LI Node), Ivana T. Croghan, PhD (Mayo Clinic, OV Node), Lenard A. Adler, MD (New York University School of Medicine, NY Node), Roger D. Weiss, MD (McLean Hospital, Harvard Medical School, NNE Node), Jeffrey D. Leimberger, PhD (Duke Clinical Research Institute, DSC), Daniel F. Lewis (University of Cincinnati, OV Node), Emily M. Dorer, MS (University of Cincinnati, OV Node).
This is the Primary Outcomes Article for CTN-0029. High smoking rates in adults with attention deficit hyperactivity disorder (ADHD) and nicotine's amelioration of ADHD suggest that effective ADHD treatment might facilitate abstinence in smokers with ADHD. National Drug Abuse Treatment Clinical Trials Network (CTN) protocol CTN-0029 evaluated whether or not using osmotic-release methylphenidate (OROS-MPH) to treat ADHD enhances response to smoking cessation treatment in smokers with ADHD. This study was a randomized, double-blind, placebo-controlled, 11-week trial with a one month follow-up conducted at six community treatment providers between December 2005 and January 2008. Adults meeting DSM-IV criteria for ADHD and interested in quitting smoking were randomized to OROS-MPH titrated to 72 mg/day (n=127) or placebo (n=128). All participants received brief weekly individual smoking cessation counseling for 11 weeks and 21 mg/day nicotine patch starting on the smoking quit day (day 27) through study week 11. Outcome measures included prolonged smoking abstinence and DSM-IV ADHD Rating Scale (ADHD-RS) score. Analysis of study results determined that prolonged abstinence rates for the OROS-MPH and placebo groups did not differ significantly. OROS-MPH, relative to placebo, evidenced a greater reduction in DSM-IV ADHD-RS score and in cigarettes per day during the post-quit phase. OROS-MPH, relative to placebo, also increased blood pressure and heart rate to a statistically, but not clinically, significant degree. Medication discontinuation did not differ significantly between treatments.
Conclusions: ADHD treatment did not improve smoking cessation success. OROS-MPH, relative to placebo, was effective in treating ADHD and was safe and generally well-tolerated in this healthy sample of adult ADHD smokers. (Article (Peer-Reviewed), PDF, English, 2010)
Keywords: Attention Deficit Hyperactivity Disorder (ADHD) | Concerta | CTN primary outcomes | Nicotine replacement therapy | Osmotic-Release Methylphenidate (OROS-MPH) | Pharmacological therapy | Smoking | Journal of Clinical Psychiatry (journal)
Document No: 387, PMID: 20492837, PMCID: PMC3151610.
Submitted by Jack Blaine, Publications Subcommittee, 5/27/2010.